ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an
end-to-end commercial biopharmaceutical company dedicated to
manufacturing, marketing and developing specialty plasma-derived
biologics, today announced that it has received U.S. Food and Drug
Administration (“FDA”) approval for its tenth ADMA BioCenters
plasma collection facility located in Laurel, Maryland. This plasma
collection facility commenced operations and initiated source
plasma collection in the first half of 2023. With the FDA approval
announced today, this facility is now licensed to introduce into
interstate commerce human source plasma for further manufacturing
in the U.S.
“The successful expansion of ADMA’s plasma collection network
accomplishes the Company’s goal of plasma supply self-sufficiency,
supports ongoing revenue growth objectives, and further enhances
ADMA’s profitability outlook. The approval is a testament to the
BioCenters team’s tireless commitment, and we thank the FDA for its
efforts and expeditious review of the Laurel, MD Biologics License
Application (“BLA”),” said Adam Grossman, President and Chief
Executive Officer of ADMA.
“This milestone achievement has been several years in the
making, and we commend our dedicated staff in making this
achievement possible from both a timing and budgeting standpoint.
We now anticipate that our fully FDA-licensed plasma collection
center network will support the rapidly growing production needs
for our IG portfolio,” said Brian Lenz, Executive Vice President,
Chief Financial Officer, and General Manager, ADMA BioCenters.
This new, state-of-the-art plasma collection center features
automated registration, high-tech collection equipment designed to
shorten the donation process, free Wi-Fi wireless network in the
donor collection area, individual flat-screen TVs with cable at
each donor station, and highly trained and certified staff who put
donor comfort and safety first. At full capacity, the plasma center
expects to maintain a staff of 50 highly trained healthcare
workers. This center is approved to use the state-of-the-art
Haemonetics NexSys Persona® plasma collection system.
To learn more about the ADMA BioCenters donation process, and to
schedule an appointment, please visit: www.admabiocenters.com,
or visit in person at 12647 Laurel Bowie Rd., Laurel, MD 20708.
About ADMA BioCenters ADMA
BioCenters is an FDA-licensed network specializing in the
collection of human plasma used to make special medications for the
treatment and prevention of diseases. Managed by a team of experts
who have decades of experience in the specialized field of plasma
collection, ADMA BioCenters provides a safe, professional and
pleasant donation environment. ADMA BioCenters strictly follows FDA
regulations and guidance and enforces cGMP (current good
manufacturing practices) in all of its facilities. For more
information about ADMA BioCenters, please visit
www.admabiocenters.com.
About ADMA Biologics, Inc.
(ADMA)
ADMA Biologics is an end-to-end commercial
biopharmaceutical company dedicated to manufacturing, marketing and
developing specialty plasma-derived biologics for the treatment of
immunodeficient patients at risk for infection and others at risk
for certain infectious diseases. ADMA currently manufactures and
markets three United States Food and Drug Administration
(FDA)-approved plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases:
BIVIGAM® (immune globulin intravenous, human) for the treatment of
primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin
intravenous, human – slra 10% liquid) for the treatment of PI; and
NABI-HB® (hepatitis B immune globulin, human) to provide enhanced
immunity against the hepatitis B virus. ADMA manufactures its
immune globulin products at its FDA-licensed plasma fractionation
and purification facility located in Boca Raton, Florida. Through
its ADMA BioCenters subsidiary, ADMA also operates as an
FDA-approved source plasma collector in the U.S., which provides
blood plasma for the manufacture of its products. ADMA’s mission is
to manufacture, market and develop specialty plasma-derived, human
immune globulins targeted to niche patient populations for the
treatment and prevention of certain infectious diseases and
management of immune compromised patient populations who suffer
from an underlying immune deficiency, or who may be immune
compromised for other medical reasons. ADMA has received U.S.
Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865
and European Patent No. 3375789, among others, related to certain
aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains “forward-looking
statements” pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, about ADMA Biologics,
Inc. and its subsidiaries (collectively, “ADMA”, “we,” “our” or the
“Company”). Forward-looking statements include, without limitation,
any statement that may predict, forecast, indicate, or imply future
results, performance or achievements, and may contain such words as
“anticipate,” “intend,” “target,” “plan,” “expect,” “believe,”
“will,” “is likely,” “will likely,” “should,” “could,” “would,”
“may,” or, in each case, their negative, or words or expressions of
similar meaning. These forward-looking statements also include, but
are not limited to, statements about ADMA’s future results of
operations (including, but not limited to, revenue growth), plasma
supply self-sufficiency and production needs. Actual events or
results may differ materially from those described in this press
release due to a number of important factors. Current and
prospective security holders are cautioned that there also can be
no assurance that the forward-looking statements included in this
press release will prove to be accurate. Except to the extent
required by applicable laws or rules, ADMA does not undertake any
obligation to update any forward-looking statements or to announce
revisions to any of the forward-looking statements. Forward-looking
statements are subject to many risks, uncertainties and other
factors that could cause our actual results, and the timing of
certain events, to differ materially from any future results
expressed or implied by the forward-looking statements, including,
but not limited to, the risks and uncertainties described in our
filings with the U.S. Securities and Exchange Commission, including
our most recent reports on Form 10-K, 10-Q and 8-K, and any
amendments thereto.
COMPANY CONTACT:Skyler BloomSenior Director,
Corporate Strategy and Business Development | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam MartinManaging
Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
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